Impact inserter mechanism for implantation of a biomedical device

ABSTRACT

The specification discloses an impact inserter for implanting a biomedical device such as a three-dimensional electrode device into a biological tissue. An electrode device useful as a neuron interface or as a cortical implant, and which may be implanted using the inserter, is also disclosed. The inserter includes an impact transfer mass for placement in contact with the rear side of the biomedical device, and a piston mechanism operably arranged and configured to strike the impact transfer mass.

RELATED APPLICATIONS

This application is a continuation in part of application Ser. No.07/432,992 filed Nov. 7, 1989, now U.S. Pat. No. 5,215,088.

BACKGROUND OF THE INVENTION

1. Field

The present invention is directed toward a three-dimensional electrodedevice and a method of manufacturing such a device. The device may beparticularly useful for neuron interface, and more specifically as acortical implant for vision prosthesis.

2. State of the Art

It is well known that messages are transmitted throughout the nervoussystem by means of electrical signals. Electrical signals are generatedby various parts of the body, such as the sensory organs, and aretransmitted to the brain. The brain in turn generates electrical signalsto control muscular and other activity. Certain devices have beendeveloped to electrically interface with neural tissue to either receivemessages from or deliver messages to the neurons.

For example, various attempts have been made to provide a corticalimplant to interface with the region of the cortex corresponding to thesense of sight. Using such implants, blind persons have been made toperceive simple sensations of sight in the form of spots of light,referred to as "phosphenes, " in simple geometric patterns Suchinterface systems typically include a two-dimensional array of flatelectrodes.

These attempts have not been completely satisfactory. Two-dimensionalarrays reside on the surface of the cortex. However, the neurons thatinitiate phosphene perception lie somewhat below the surface. The depthof these neurons is believed to be about 1.5 mm. In surface arrays,relatively high current, in the neighborhood of 3 mA is required tostimulate neurons. Such high currents may pose pathogenic problems. Inaddition, a phenomenon has been experienced in which when two nearbyelectrodes are energized, signals from the electrodes interact toproduce a phosphene at an anomalous geometric position. Such electrodeinteractions severely limit the number of electrodes that can be used insurface arrays.

To induce in a blind person the perception of sight, it appearsnecessary to produce a large number of contiguous phosphenes, similar tothe way a cathode ray tube produces a complete image by appropriateillumination of a large number of contiguous "pixels" on a televisionscreen. Because of their construction and limited electrode spacing,previously known implants have not produced the sensation of asufficient number of contiguous phosphenes to produce an acceptablesense of vision.

Also, some means must be provided to address each of the electrodesindividually. One approach has simply been to run a wire to eachelectrode. With even a small to moderate number of electrodes, such abundle of wires is cumbersome and disadvantageous, since these wiresmust lead from the blind person's cerebral cortex to some point externalto the blind person's head.

Electrode arrays are also used in applications other than as neuroninterfaces. For example, various arrays of photoreceptors orlight-emitting diodes are used for image sensing or image producingdevices. It is often useful to form such arrays of semiconductormaterial, particularly silicon, because of a wide variety ofcharacteristics that may be imparted to semiconductors by means of suchprocesses as doping, etching, etc. Such arrays are typically formed of"wafers" of semiconductor material. The electrodes on these wafers areformed by conventional photolithographic techniques. Such wafers mayhave thicknesses of a millimeter or less, with the electrodes formed onsuch wafers being in the range of a few microns in thickness.

There remains a need for a three-dimensional semiconductor device thathas the capability of providing a large number of electrodes that may beaddressed individually for signal transmission and/or reception. Such anarray would be particularly advantageous as a neuron interface device,such as a cortical implant for vision prosthesis. Such athree-dimensional array of elongated electrodes may be positioned withthe active tips of the electrodes at a depth in the cortex where verylocalized stimulation of or recording from neurons may more effectivelytake place. Such an array would preferably be strong and rigid. Thearray would preferably be formed of a semiconductor material, such assilicon, to make use of the unique electrical properties ofsemiconductors. The individual electrodes would each be preferablyaddressable without the need for a large number of lead wires, such asby the provision of a multiplexing system.

SUMMARY OF THE INVENTION

The present invention provides a three-dimensional electrode device.This device may be particularly adapted as a neuron interface device,and more specifically, a cortical implant. A base of rigid material isprovided. A plurality of elongated electrodes are mounted to the base toextend away from the base. The electrodes are electrically isolated fromeach other at the base by means of a second material positioned betweenthe electrodes. Each of the electrodes has a distal end. Signalconnection means is linked with the electrodes for providing electricalconnection to each of the electrodes individually.

The electrodes may advantageously be spire shaped, or tapered from thebase toward the distal ends. The electrodes may also advantageously beformed of a semiconductor material, such as silicon. In one embodiment,the electrodes are electrically isolated from each other by means ofsemiconductor doped with an impurity. In another embodiment, theelectrodes are electrically isolated from each other by glass.

The signal connection means may include an electrical gate associatedwith each of the electrodes. The electrical gates may be arranged in atwo-dimensional array and multiplexed to be addressable individually.The electrodes also preferably include a charge transfer material at thedistal ends.

The invention also provides a method of manufacturing an electrodedevice. A three-dimensional chunk of a first material is provided. Afirst surface of the chunk is impinged to a preselected depth with asecond material to provide isolating regions of the second material andisolated regions of the first material between the isolating regions.The second material is adapted to provide electrical isolation betweenthe isolated regions. A second surface of the chunk is sawed oppositethe first surface at a preselected depth in criss-crossing channels toprovide pillars of the first material between the channels. The pillarsare electrically isolated from each other by means of the isolatingmaterial. The pillars are tapered to reduce their cross-sectional sizetoward their distal ends, and the distal ends are metallized.

In one embodiment, the method includes the additional step ofpositioning electrical gates upon the first surface of the chunk toprovide electrical connection to each of the pillars.

In a preferred embodiment, the method further comprises the step ofcoating the pillars and the base with an ion impermeable material. Thesemiconductor device may be advantageously used as a neuron interfacedevice. This neuron interface device may be a cortical implant forvision prosthesis.

The first material may be a semiconductor material. In one embodiment,the second material is a semiconductor material doped to provide pnjunctions between the first material and the second material. In anotherembodiment, the second material is glass.

The invention provides an electrode device that has the capability ofproviding a large number of electrodes that may each individually beaddressed for signal transmission and/or signal reception. This devicemay be particularly advantageous for a neuron interface, andparticularly a cortical implant for a vision prosthesis. Since thedevice is three dimensional, the active tips of the electrodes may bepositioned at a depth in the cortex where interface with neurons maymore effectively and directly take place. The array is strong and rigid.In preferred embodiments, the array is multiplexed such that only asmall number of lead wires need to be attached.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective illustration of a semiconductor device of theinvention, particularly adapted for neuron interface or visionprosthesis;

FIG. 2 is a perspective schematic illustration of the device of FIG. 1showing multiplexing circuitry;

FIG. 3 is a side view of a block with an aluminum layer deposited inpreparation for a thermomigration process;

FIG. 4 is a side view of the block of FIG. 3 with aluminum pads havingbeen prepared;

FIG. 5 is a side view of the block of FIG. 4 after the aluminum padshave been thermomigrated through the silicon block;

FIG. 6 is a side view of a silicon block with kerfs cut in preparationfor a glass melting process;

FIG. 7 is a side view of the block of FIG. 6 with glass melted into theprepared kerfs and excess glass removed;

FIG. 8 is a side view of a block after columns have been cut with adicing saw to prepare electrode columns;

FIG. 9 is a top view of a block after the column dicing process;

FIG. 10 is a top view of a block holder for the etching process;

FIG. 11 is a side view of the block holder of FIG. 10;

FIG. 12 is a top view of a swirling etch system;

FIG. 13 is a side view of the system of FIG. 12;

FIG. 14 is a side view of a static etch system;

FIG. 15 is a side view of columns etched into electrode shape with thealuminum pads bonded onto the back of each electrode;

FIG. 16 is a side view of the electrodes of FIG. 15 with lead wires andpassivating coating;

FIG. 17 is a scanning electron micrograph of an array after the dicingprocess to produce columns;

FIG. 18 is a scanning electron micrograph of the base of the columnsafter the swirl etch process;

FIG. 19 is a scanning electron micrograph of the tips of the columnsafter the swirl etch process;

FIG. 20 is a scanning electron micrograph of an array after the staticetch process;

FIG. 21 is a side view of a pneumatic implant inserter of the invention;and

FIG. 22 is a side view of a mechanical implant inserter of theinvention.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENT

FIG. 1 is a perspective illustration of a three-dimensional electrodearray of the invention. This electrode array is specifically adapted tobe used as a neuron interface device and to be implanted in the cortexof the brain. More specifically, the illustrated electrode array isadapted to be used as a vision prosthesis for a blind person. A visualimage is reduced by some means, for example, a video camera, to anelectrical signal that is then provided to the electrode array ofFIG. 1. This electrical signal is used to control the amplitude of thesignal provided to each electrode in the array. An actual image isscanned to produce the series of signals. This series of electricalsignals is then multiplexed across the electrode array to producephosphenes corresponding to the image. The blind person perceives theimage in his mind, thus providing a usable sense of sight.

The electrode array of FIG. 1 includes a base 30 to which are connecteda plurality of electrodes, of which electrode 32 is typical. As shown,each electrode 32 is spire-shaped. In other words, electrodes 32 arerelatively large in cross-sectional size at their bases 36 where theyconnect to base 30 and taper toward distal ends 34. Electrodes 32 areelectrically isolated from each other at base 30. Base 30 and electrodes32 are formed substantially of semiconductor material, preferablysilicon.

FIG. 2 is a schematic representation of the electrode device of FIG. 1showing multiplexing circuitry associated with the electrodes 32. Aplurality of AND gates, of which gate 40 is typical, are associated withthe back side 42 of base 30. Face 42 is a two-dimensional flat plane.Using conventional photolithographic techniques, gates 40 may be formedas two-gate field effect transistors (FET) which are formed over andelectrically connected to the projections of each of electrodes 32.Electrodes 32 are electrically isolated one from another by means ofchannels 38 of isolating material. The portions of base 30 connected toelectrodes 32 are isolated regions of which region 44 is typical. Asshown, gates 40 are connected to these isolated regions.

The signal produced by the imaging device, such as a video camera, isfed into input 46. The signal is provided to all of the gates 40 at thesame time. Whether or not a particular gate is activated to provide thissignal to its associated electrode 32 depends on the multiplexingcircuitry. Gates 40 allow for bidirectional flow of current through eachelectrode 32. A clock provides an oscillating series of logic "1" andlogic "0" signals at a selected frequency to input 48.

Gates 40 are connected to an X-axis shift register 54 and a Y-axis shiftregister 56. Shift registers 56 and 58 are linked by a carry 60. Thegate 40 that has a "1" logic level on both its respective row and columnis energized. In FIG. 2, gate 58 is the energized gate. Gate 58 wouldtherefore provide the electrical signal (which is supplied to all gates40) to be transmitted only to its associated electrode 32. Thus, shiftregisters 54 and 56 allow the entire array to be "scanned," oneelectrode at a time. The implant needs only five wires attached to it:two power supply lines (not shown), a ground (not shown), a clock, andthe signal line.

The electrode array is three dimensional. The electrodes are intended topenetrate the cortical tissue and to position the electrode tips 34 nearthe neurons responsible for phosphene perception. Because the activecurrent-passing tips 34 are in close proximity to these neurons, arelatively lower current can be used for the signal supplied to thearray. Such currents can be in the neighborhood of 1 to 100 μA. Theclose proximity of tips 34 to the neurons and the lower currents alsoreduces electrode interaction, thus reducing anomalous phosphene effectsand allowing for a higher number of contiguous phosphenes.

The isolation regions 38 are formed in any appropriate manner whichprovides a rigid and strong base 30. At present, two methods aredisclosed for providing such a base having isolation regions. One isthermomigration, and the other is a method that places channels of glassin between the isolated regions 44. The array described includes 100electrodes. However, a much larger or smaller number of electrodes maybe fashioned if it is deemed useful in the particular applicationinvolved. The block or "chunk" from which the electrode arrays arefabricated is a 1.7 millimeter thick monocrystalline n-doped silicon,with a resistivity of 1-10 ohm-cm.

Thermomigration is described generally in U.S. Pat. No. 3,898,106 issuedto Cline et al., entitled "High Velocity Thermomigration Method ofMaking Deep Diodes; High Temperature Melting," the disclosure of whichis incorporated herein by reference. The method used in the presentinvention to achieve thermomigration is similar to that described inU.S. Pat. No. 4,001,047 issued to John K. Boah, entitled "TemperatureGradient Zone Melting Utilizing Infrared Radiation," the disclosure ofwhich is also incorporated herein by this reference.

A description of the thermomigration technique is described in referenceto FIGS. 3-5. A block 70 of 1.7 mm thick monocrystalline n-doped siliconis provided having a resistivity of 1-10 ohm-cm. A 6 micron thick layer72 of aluminum is deposited on back surface 74 of block 70. Back surface74 will become the surface 42 (FIG. 2) of the array. Referring to FIG.4, conventional photolithographic/etching techniques are used to formone hundred 300 micron by 300 micron rectangular pads 78. These pads arethen annealed to the silicon block 70.

The silicon block 70, now coated with the 100 aluminum pads, is thenplaced in a thermomigration oven with a positive temperature gradient inthe direction of arrow 80. Each pad 78 becomes a localizedaluminum-silicon "melt" that propagates in the direction of thetemperature gradient through the silicon block 70 in relatively straightcolumns. The aluminum passing through the silicon leaves behind tracealuminum to form the columns 82 (FIG. 5) of aluminum-doped silicon.After thermomigration is complete, the front surface 84 of the block andthe back surface 74 are polished. The aluminum-doped silicon is revealedby a staining procedure. Each p+ doped column 82 forms a diode in block70 between column 82 and the surrounding n-type block. Therefore, a pairof back-to-back diodes is created between each adjacent pair of columns82, which become electrodes 32 after the shaping process is complete.Electrical isolation of electrodes 32 is thereby achieved and currentleakage between electrodes is limited to back-biased leakage acrossthese diodes.

Isolation regions 38 may also be formed by a glass melt processdiscussed in reference to FIGS. 6 and 7. A diamond dicing saw equippedwith a 0.125 mm thick blade, is used to make a series of 0.25 mm deeporthogonal cuts 90 into block 70. Eleven cuts are made with even spacingalong one direction. The silicon is rotated 90° and 11 additional cutsare made with the same spacing orthogonal to the first set. This cuttingprocess leaves 100 silicon stubs 92, each 0.25 mm high.

Dicing saws are used in the fabrication of silicon computer chips. Suchsaws are used to saw apart large numbers of identical chips from a blockon which they have formed. In the present application, however, thedicing saw is used to form a three-dimensional structure in thesemiconductor block.

Referring to FIG. 7, after stubs 92 are formed, a slurry is prepared ofglass frit (Corning Glass Works, 7070), and methyl alcohol. This slurryis dripped onto front surface 74. The alcohol in the slurry wets thesilicon surface and carries the glass powder down into the saw kerfs 90.The methanol evaporates quickly. This dripping process is continueduntil there is a layer of glass powder approximately 0.25 to 0.5 mmabove the top surface of stubs 92.

The coated silicon chip or block 70 is then placed in a computercontrolled oven. The oven is evacuated and the temperature quicklyincreased to a temperature sufficient to melt the glass frit, allowingit to flow while not melting the silicon. The temperature is held atthis level for 60 minutes, after which the oven is allowed to cool toroom temperature. The vacuum in the oven is released and thesilicon/glass chip is removed. Any large bubbles in the glass surfaceare then broken with a sharp probe.

The block 70 is placed in the oven again and the oven is evacuated andthe temperature again increased to the same temperature previously usedto melt the glass. The temperature is held at this level for 50 minutes,at which time the vacuum is released. Releasing the vacuum forces anybubbles in the glass to shrink in size. The temperature is maintainedfor an additional 10 minutes, after which the temperature is slowlydecreased until the glass is cooled. This melting process removes anylarge bubbles from the glass and minimizes internal stresses in theglass while assuring good adhesion at the glass/silicon interface. Theglass remaining above the level of stubs 92 is then ground off, and thestubs 92 and the glass is then polished to provide a smooth surface asshown in FIG. 7 with regions of glass 94 between stubs 92.

A description of the formation of electrodes 32 is made in reference toFIGS. 8-14. One starts with a block 70 that has had either thethermomigration process performed as discussed in reference to FIGS. 3-5or the glass isolation region process discussed in reference to FIGS. 6and 7. The computer-controlled dicing saw is used to produce a series oforthogonal cuts in the silicon block 70. Eleven cuts are made along oneaxis. The block is then rotated by 90° and 11 more cuts are madeorthogonal to the first set of cuts. Each cut is 1.5 mm deep and has akerf of 270 microns. In thermomigrated blocks, the cutting is alignedbetween the aluminum-doped columns 82, producing electrodes 32, whichare p+ doped. If the glass melt procedure has been used, the cuts aremade as shown in FIG. 8 such that the glass regions 94 isolateelectrodes from each other.

The dicing process to produce columns 32 is disclosed in terms oforthogonal cuts to produce pillars having square cross-sections.However, pillars having other types of cross-sections may be useful andadvantageous. For example, another scheme involves the use ofcriss-crossing cuts at 60° angular separation to produce a hexagonalarray of hexagonally-shaped pillars. Pillars of hexagonal cross-sectionsmay provide electrodes with denser packing than with square pillars.

FIG. 9 illustrates the substrate or block after it has been cut with thedicing saw to produce 100 columns 98 by forming a first set of cuts 100and a second set of cuts 102 orthogonal to first set 100. As also shown,this cutting process leaves 40 rectangular fins 104 and four cornerposts 106. Fins 104 and corner posts 106 are left in place temporarilyto facilitate subsequent processing. Cuts 100 and 102 are made from thefront side 84 of the block so that the thermomigration or glass meltingprocedures provides that the electrodes 32 be isolated from each otherat base 30. FIG. 17 is a scanning electron micrograph of the array aftercolumns 98 have been formed by the dicing process.

After the columns 98 which form the basis for electrodes 32 have beenformed, these columns 98 must be etched to produce pyramid orspire-shaped electrodes 32 as shown in FIG. 1. This etching process isdescribed in reference to FIGS. 10-14. A holder is formed of acylindrical piece 110 of Teflon that has a diameter of 0.435 inches. Asquare hole 112 that is 0.25 inches on each side 0.080 inch deep ismachined into piece 110. Hole 112 receives block 70 and securely holdsit during the etching process. The rectangular block 70 is placed inhole 112 such that block 70 registers in a press- or friction-fit withinholder 110. Block 70 is placed such that columns 98 extend toward theopening of hole 112. When block 70 is placed within hole 112, the topsof columns 98 are approximately flush with the upper surface 116 ofholder 110.

Referring to FIG. 13, with block 70 in holder 110, as described, holder110 is mounted by means of stock 114 to a clock motor 115, and block 70is immersed in an acid bath of five percent hydrofluoric acid and 95percent nitric acid etchant 120. Block 70 is positioned approximately0.125 inches above a magnetic stir bar 122 held within jar 124. Jar 124has an approximately 1.9 inch diameter. Jar 124 resides on the surfaceof a magnetic stir plate 126 that has a magnetic mechanism to cause stirbar 122 to rotate at a selected rotational speed.

FIG. 12 illustrates a top view of this swirling etch method. Magneticstir bar 122 is caused to rotate in the direction of arrow 130 at apreferred speed of approximately 375 revolutions per minute. Holder 110is caused to rotate in the direction of arrow 132 at a rotational speedof approximately 4 revolutions per minute. Block 70 is swirl etched inthis manner for approximately three minutes to produce thin columns withpolished sides as shown in FIGS. 18 and 19.

The final structure of the electrodes is produced by a wet staticchemical etching as illustrated in FIG. 14. In this arrangement, holder110 is placed in an "L"-shaped handle 140 and immersed in the samesolution 120 for a period of approximately two to three minutes. Theresult of this procedure is to sharpen the electrodes to the spire shapeshown in FIG. 20.

As can be seen in FIG. 20, the spires 98 have relatively largecross-sectional sizes at their bases and taper toward their tips. Thebases of the columns are roughly square in cross-section because at thispoint the etchant has had the least effect. These spire-shaped ortapered columns provide for effective insertion of the array intocortical tissue without doing undue harm to the tissue. The columns arepointed at their tips to pierce the tissue and increase gradually incross-section toward their bases. Thus, after the tips of the electrodesare inserted, the tissue is gradually spread apart until the array isfully inserted. The relatively large cross-sectional size at the base ofthe electrode provides increased strength for each electrode.

Once the columns 98 have been formed to provide the basis for theelectrodes, ohmic contact must be provided to the back of eachelectrode. A grid of 200 micron by 200 micron square aluminum pads isdeposited over the back surface of each column 98. This process isidentical to the initial steps of the thermomigration process. Thesealuminum pads are used whether the thermomigration process or the meltedglass process is used to produce the electrodes. The aluminum pads areannealed to the back surface of their respective columns, one pad toeach column. This process forms a low resistance ohmic contact to eachcolumn 95. At this point fins 104 and corner posts 106 are removed withthe dicing saw.

Referring to FIG. 15, the tips 34 must be then formed to provide activecurrent passing electrodes. In other words, some means must be providedto transduce electric charge to ionic charge in the neural tissue. Inthe disclosed array, metal is used as such a charge transfer medium.However, other materials may be used. For example, iridium oxide may beused as an effective charge transfer material. Tips 34 are driventhrough a metallic foil such that the top 1000 microns of each spireemerge from the surface of the foil. The array, with foil is thentransferred to an electron beam evaporator and a few microns of platinumor iridium (which are metallic substances) are deposited on the tips ofthe electrode. The metal foil is removed, and the array, with its metalcoated tips 34 is annealed at low temperature. This annealing drives asmall amount of the metal into the silicon and forms a thin layer ofmetal silicide at the metal/silicon interface. The metal silicideprovides an ohmic contact between the metal on the tips 34 and thesilicon spires 98. The metal surface forms an active current passingelectrode between the silicon and the neurons in the brain.

Referring to FIG. 16, lead wires 152 are wire bonded to the aluminumpads 150 on the back surface 74 of block 70. This bonding process is astandardized process using ultrasonic bonding of insulated 25 microngold wires to the aluminum pads 150. The bonded wires are secured to theback side of the array with a layer of polyimide, which is subsequentlycured in an oven.

The entire structure (with the exception of the tips 34 of eachelectrode) must then be insulated or passivated. Passivation means tocoat the array with a substance to prevent ion transfer between neuraltissue and the array. In one passivation method, polyimide, coupled toaluminum chelate primer (Hitachi PIQ coupler) is used. The entire arrayis immersed in aluminum chelate primer and the excess aluminum chelateprimer is drained. The entire array with the lead wires is then ovencured.

In an identical fashion, the array is immersed in polyimide and theexcess polyimide drained. The entire array with lead wires is then ovencured. The tips of the array are then pushed through a thin foil, andthe polyimide and the aluminum chelate primer are etched from theexposed tips of the spires in an oxygen plasma. The 25 micron lead wiresis then soldered to a percutaneous connector. The back of the connectoris then filled with epoxy.

Another passivation technique involves the use of silicon nitride andsilicon dioxide, instead of the polyimide. Silicon nitride, whenproperly deposited on a silicon dioxide coating, can provide verylong-term passivation.

FIG. 21 is a side view of a pneumatic impact inserter of the invention,.The inserter of FIG. 21 is used to implant the electrode array of FIG. 1into the cortex of the brain. The cortex of the brain has a consistencysomewhat like gelatin. The electrode array of FIG. 1 is pressed into thecortex with tips 34 being inserted first until base 30 comes intocontact with the cortical tissue. If the electrodes 32 are slowly pushedinto the cortical tissue, the tissue tends to deform and dimple underthe array. However, if the array is rapidly inserted by a sharp impulseforce, the electrodes 32 penetrate the cortical tissue withoutsubstantial deformation of the tissue.

The impact inserter of FIG. 21 includes a delivery tube 160, a piston162, an insertion mass 164, and an end spring 166. Delivery tube 160 isa cylindrical tube, which may be formed, for example, of aluminum.Piston 162 is a cylindrical mass sized to slidingly fit within tube 160.In a working model of the inserter of FIG. 21, tube 160 has an insidediameter of 0.477 cm and a length of 17.4 cm. Piston 162 has an outsidediameter of 0.468 cm. and a mass of 1.76 grams. In the illustratedembodiment, piston 162 is formed of stainless steel. The electrode arrayis placed on face 168 of insertion mass 164 with electrodes 32 pointingaway from face 168.

A pressure tube 170 connects to tube 160 at cap 172. Before the array isinserted into the cortex, piston 162 is held in the position shown inFIG. 21 by means of a vacuum being presented in tube 170 behind piston162. When it is desired to insert the array into the cortex, an airpressure pulse is supplied to tube 170 to force piston 162 to slidetoward insertion mass 164. The small cylindrical extension 174 on piston162 enters a cylindrical channel 176, formed in tube 160 and strikes therear face 178 of insertion mass 164. Insertion mass 164 has a mass of0.9 grams. Insertion mass 164 accepts momentum transfer from piston 162to achieve a high velocity impact insertion of the array into thecortex. After the array has been inserted into the cortex, spring 166returns insertion mass 164 to its original position. Spring 166 alsocontrols the distance of travel of insertion mass 164 after it has beenstruck by piston 162. Useful values for the pressure applied at tube 170for insertion is a value of 12 pounds per square inch of pneumaticpressure applied for a period of 0.13 seconds.

FIG. 22 illustrates an alternative impact inserter for electrode arraysof the invention. The impact inserter of FIG. 22 uses a mechanicalspring rather than pneumatic pressure to achieve insertion. The impactinserter includes a cylinder 190, a sliding plunger 192, a trigger 194,a spring 196, an insertion mass 198, and a spring 200. The array isplaced on face 202 of the mass 198 with the electrodes pointing awayfrom face 202. The user grasps cylinder 190 and pulls back trigger 194,which is connected to plunger 192, to thereby withdraw plunger 192 to aposition where trigger 194 may be rotated to move into a notch 204. Innotch 204, trigger 194 is held in place against face 206 by spring 196.To insert the array, the user rotates trigger 194 out of notch 204.Spring 196 then urges plunger 192 rapidly toward insertion mass 198 tostrike mass 198 on face 208, to deliver momentum to mass 198 and tothereby quickly insert the array into the cortex.

While both the inserters of FIGS. 21 and 22 are useful, it is currentlybelieved that the pneumatic inserter of FIG. 21 is preferable, asproviding greater control over the parameters of insertion and providingfor more consistent insertion results. In any case, the impact transfermass should have a sufficient mass that upon being struck by the piston,there is an inertial energy transfer adequate to implant the electrodearray to the desired depth. An impact transfer mass whose mass isbetween about 0.3 and about 3 times the mass of the piston gives usefulresults. It is also desirable that the impact transfer mass be betweenabout 20 times and about 100 times the mass of the electrode devicebeing inserted.

This invention was made with government support under Grant #EET 8808859awarded by the National Science Foundation. The government has certainrights in this invention.

Reference herein to details of the illustrated embodiment is notintended to limit the scope of the appended claims, which themselvesrecite those features regarded important to the invention.

What is claimed is:
 1. An inserter for implanting an electrode array ina biological tissue, comprising:a casing having first and second endsand enclosing a chamber; a piston disposed within said casing andslidable between a first and a second position; piston actuating meansoperably associated with said piston for urging said piston to saidsecond position; an impact transfer mass slidably disposed within saidcasing, having a first end and a second end, said second end extendingslidably through said second casing end and configured for placementadjacent and in contact with a rear side of an electrode array to beimplanted, and said impact transfer mass being positioned to have saidfirst end contacted by said piston when said piston is urged to saidsecond position; and spring means operably associated with said impacttransfer mass for returning said impact transfer mass to a readyposition following an impact by said piston.
 2. The inserter of claim 1,wherein said first end of said casing has an opening with a tubingarranged therein to communicate to the interior of the chamber, and saidpiston actuating means comprises a pneumatic pulse source connected tosend a pneumatic pulse through said tubing into said chamber.
 3. Theinserter of claim 2, further including piston retraction means operablyassociated with said piston and said casing for releasably holding saidpiston in said first position.
 4. The inserter of claim 3, wherein saidpiston retraction means comprises suction means connected to said tubingto apply suction to said chamber and said piston.
 5. The inserter ofclaim 1, wherein said casing has a slot therein, and said pistonactuating means comprises a spring mechanically associated with saidpiston first end and a trigger slidably seated in said slot andconnected to said piston for a user to urge said piston to said firstposition and thereby compress said spring.
 6. The inserter of claim 5,wherein said slot has a notch and said trigger is configured to bemovably seated in said notch, said notch being arranged with respect tosaid spring and said casing such that when said trigger is seated insaid notch said piston is held in said first position.
 7. The inserterof claim 1, wherein said impact transfer mass has a mass selected toprovide sufficient inertial energy transfer to implant said electrodearray upon receiving an impact from said piston.
 8. The inserter ofclaim 7, wherein said selected mass is from about 0.3 to 3.0 times themass of said piston.
 9. The inserter of claim 1, wherein the impacttransfer mass has a mass which is between about 20 times and about 100times the mass of an electrode array to be inserted.
 10. An impacttransfer mechanism for implanting a biomedical device having an array ofprongs in a biological tissue, comprising:a casing having first andsecond ends and enclosing a chamber; a piston disposed within saidcasing and slidable between a first and a second position; pistonactuating means operably associated with said piston for urging saidpiston to said second position; an impact transfer mass slidablydisposed within said casing for movement between a resting position andan implanting position, and having a first end and a second end, saidsecond end extending slidably through said second casing end andconfigured for placement adjacent and in contact with a rear side of abiomedical device having an array of prongs on a forward side, saidimpact transfer mass being positioned to be urged to said implantingposition by an impact received from said piston on said first end; andspring means operably associated with said impact transfer mass forbiasing said impact transfer mass to said resting position.
 11. Themechanism of claim 10, wherein said first end of said casing has anopening with a tubing arranged therein to communicate to the interior ofthe chamber, and said piston actuating means comprises a pneumatic pulsesource connected to send a pneumatic pulse through said tubing into saidchamber.
 12. The mechanism of claim 11, further including pistonretraction means operably associated with said piston and said casingfor releasably holding said piston in said first position.
 13. Themechanism of claim 12, wherein said piston retraction means comprisessuction means connected to said tubing to apply suction to said chamberand said piston.
 14. The mechanism of claim 10, wherein said casing hasa slot therein, said piston actuating means comprises a springmechanically associated with said piston first end and a triggerslidably seated in said slot and connected to said piston for a user tourge said piston to said first position and thereby compress saidspring.
 15. The mechanism of claim 10, wherein said impact transfer masshas a mass selected to provide sufficient inertial energy transfer tourge the prongs of said biomedical device to penetrate the tissue to adesired depth upon receiving an impact from said piston.